Eval EarlySense Bet Lowenstein Sleeplab

NCT01978340 | Withdrawn

• 1 other identifier: ES-CLC-2013_Prot_1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Conditions

Obese; Sleep Apnea, Obstructive; Central Apnea; Sleep Disorders; Poor Quality Sleep

Outcome Measures

Primary Outcomes (1)

• To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab

  the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab

  up to 12 hours

Study Arms (1)

sleeplab

Sleep Lab examined, usualy with some obesity or sleeping disorders.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

You may qualify if:

• Age 18 years or above
• Is willing to sign the consent form

You may not qualify if:

• Age \< 18 years
• Is not willing to sign the consent form

Sponsors & Collaborators

• EarlySense Ltd.: lead

Study Sites (1)

Beit Lowenstien

Raa'nana, Israel

Location

Biospecimen

Retention: NONE RETAINED

no Biospeciments will be taken.

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Sleep Apnea, Central; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Study Officials

• Tatiana Vander, MD

  Beit Lowenstein Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 19, 2016

Record last verified: 2015-12

Locations

IL (1)